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Phase Ib/II Study of SYS6020 in Relapsing/Refractory Multiple Sclerosis

ConditionMultiple Sclerosis
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTongji Hospital

About this trial

This trial is an investigator-initiated, single-arm, open-label Phase Ib/II study to observe the safety, tolerability, PK/PD characteristics, immunogenicity, and the efficacy of SYS6020 injection in participants with relapsed/refractory multiple sclerosis. The study plans to enroll participants with progressive or relapsing multiple sclerosis.

The recommended dosing regimen is as follows: a single administration dose of 45×10\^6 CAR-T cells/kg (allowing a fluctuation of ±20%), administered once a week for 6 consecutive doses.

To ensure participant safety, this study will establish a Safety Monitoring Committee (SMC). A staggered enrollment and dosing strategy will be adopted in the early stage. Two early safety evaluation will be established (after the first 3 enrolled participants complete their first 3 infusions of SYS6020, and after the first 3 enrolled participants complete their first 6 infusions of SYS6020) for comprehensive assessment.

The study plans to enroll 10-15 participants. Once the enrollment of 10-15 participants is complete, a comprehensive assessment may be conducted based on the actual progress of the study and combined with existing data. This will fully evaluate the safety, preliminary efficacy, and PK/PD/ADA data of the enrolled participants. If the overall safety of the participants is manageable, preliminary efficacy shows a positive trend, and there are value and necessity for further exploration, expanding the number of participants may be considered (up to a maximum of 25 participants in total).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Male or female participants aged 18-65 years at the time of signing informed consent.

For progressive MS: evidence of worsening disability, such as an increased Expanded Disability Status Scale (EDSS) score.

Absolute lymphocyte count ≥0.3 × 10⁹/L, absolute neutrophil count ≥1.0 × 10⁹/L, platelet count ≥50 × 10⁹/L, and hemoglobin ≥80 g/L, without red blood cell or platelet transfusion or colony-stimulating factor within 7 days before testing;

Total bilirubin ≤2 × upper limit of normal (ULN), and alanine aminotransferase and aspartate aminotransferase ≤3 × ULN;

Disqualifiers

1. Uncontrolled significant chronic disease that, in the investigator's opinion, may increase the participant's risk.

Clinically significant ventricular arrhythmia, second- or third-degree atrioventricular block, or another serious rhythm/conduction disorder;

Resting QT interval corrected using Fridericia's formula >450 msec for men or >470 msec for women;

Acute coronary syndrome, congestive heart failure, or another Grade ≥3 cardiovascular event within 6 months before first administration;

Trial design

Design model

Single group

Treatments tested in this trial

  • SYS6020 injection

    Biological/Vaccine

    SYS6020 injection is an injection of autologous CAR-T cells that have been temporarily transfected with LNP-mRNA targeting BCMA. The eligible participants will receive a single administration dose of 45×10\^6 CAR-T cells/kg (allowing a fluctuation of ±20%), administered once a week for 6 consecutive doses

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: SYS6020 injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerability

Incidence, severity, and relationship of adverse events and serious adverse events, and incidence of clinically significant laboratory abnormalities.

Time frame
From informed consent through Month 24

Secondary outcomes

1

Time to 12-Week Confirmed Disability Progression (CDP) in Participants with Progressive Multiple Sclerosis

Time to protocol-defined worsening in Expanded Disability Status Scale (EDSS) score sustained for at least 12 weeks in participants with SPMS or PPMS

Time frame
Month 24
2

Annualized Relapse Rate (ARR) in Participants with Relapsing Multiple Sclerosis

Number of protocol-defined relapses divided by total participant-years of follow-up

Time frame
Time Frame: Month 24
3

Change from Baseline in EDSS(Expanded Disability Status Scale) Score

The EDSS ranges from 0 to 10, with higher scores indicating greater neurological disability.

Time frame
Baseline and Months 1, 3, 6, 9, 12, 18, and 24
4

Proportion of Participants with an Improvement of at Least 1.0 Point in EDSS(Expanded Disability Status Scale) Score

The EDSS ranges from 0 to 10, with higher scores indicating greater neurological disability.

Time frame
Baseline and Months 1, 3, 6, 9, 12, 18, and 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tongji Hospital

Lead sponsor

CSPC Baike (Shandong) Bio-Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: